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The QMN Weekly Bulletin

Dutch Regulators to Adopt FDA’s UDI Device-Labeling System

July 7, 2017

The Dutch medical device authority has reached a voluntary agreement with industry on the use of UDI codes for medical devices, using FDA’s UDI system as a template.

The Dutch Minister of Health signed the agreement in late June with healthcare providers and device distributors and manufacturers. Under the agreement, Dutch hospitals will exclusively use the UDI system to identify and trace medical devices, making the Netherlands the first European Union member state to agree to the system.

Data requirements for Dutch signatories will be the same as under the FDA’s system. Going forward, however, Dutch regulators may amend the requirements to better conform to the UDI regulations other EU nations develop.

The FDA recently granted an extension of the labeling compliance deadline for certain lower-risk and unclassified devices, such as manual surgical tools and mechanical wheelchairs. Manufacturers of such devices will have until 2020 to comply.

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